Renal Cell CarcinomaEXO-RENAL1NCT07406646
Circulating and Urinary Exosomal miRNA in Advanced Kidney Cancer (EXO-RENAL1)
A study testing Blood and Urine Sampling for Exosomal miRNA Analysis in people with Renal Cell Carcinoma and Advanced Kidney Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This prospective cohort study will investigate whether changes in circulating and urinary exosomal biomarkers (target exosomal miRNA) are associated with response to systemic treatment in patients with advanced renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Advanced Kidney Cancer
- What is being tested?
- Blood and Urine Sampling for Exosomal miRNA Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSlovenia
- Study dates
- 2 Nov 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years).
- Histologically confirmed advanced renal cell carcinoma.
- Patients receiving systemic treatment with immune checkpoint inhibitors or targeted therapy in the first-line or second-line setting.
- Ability to provide blood and urine samples according to the study protocol.
- Signed informed consent.
Who cannot join
- Patients unable to provide required biological samples.
- Patients with missing clinical or imaging data required for treatment response assessment.
- Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Monitoring of the Circulating and Urinary Exosomal miRNA for Prediction of Response to Treatment in Patients With Advanced Kidney Cancer
This prospective cohort study will investigate whether changes in circulating and urinary exosomal biomarkers (target exosomal miRNA) are associated with response to systemic treatment in patients with advanced renal cell carcinoma. Patients treated with immune checkpoint inhibitors or targeted therapies in the first-line or second-line setting will be included. Exosomal biomarker expression will be analyzed in blood and urine samples collected during the first 16 weeks of treatment. Treatment response will be assessed using standard radiological imaging. The study aims to determine whether changes in exosomal miRNA expression after treatment initiation can serve as predictive biomarkers of objective response in advanced kidney cancer.
Read the detailed description
This is a prospective observational cohort study conducted at the Institute of Oncology Ljubljana. The study will evaluate the predictive value of circulating and urinary exosomal biomarkers (target exosomal miRNA) for response to systemic therapy in patients with advanced renal cell carcinoma.
Patients receiving immune checkpoint inhibitors or targeted therapy in the first-line or second-line treatment setting will be enrolled. The primary objective is to determine whether changes in the expression of selected exosomal miRNA in plasma after initiation of systemic treatment are associated with objective response to therapy. In addition, urinary exosomal miRNA will be evaluated as a potential predictive biomarker.
Blood and urine samples will be collected during the first 16 weeks of treatment. Each participant will provide four peripheral blood samples (10 mL each) and two urine samples (50 mL each). Radiological imaging will be performed as part of routine clinical follow-up to assess treatment response. The association between changes in exosomal miRNA expression and treatment outcomes will be analyzed.
- Conditions
- Renal Cell Carcinoma, Advanced Kidney Cancer
- Being tested
- Blood and Urine Sampling for Exosomal miRNA Analysis
- Keywords
- Exosomal miRNA, Circulating Biomarkers
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Urine Sampling for Exosomal miRNA AnalysisOther
Collection of peripheral blood and urine samples for analysis of circulating and urinary exosomal miRNA during the first 16 weeks of systemic treatment in patients with advanced renal cell carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| EXO-RENAL1 Cohort | Other | Patients with advanced renal cell carcinoma receiving standard-of-care systemic treatment (immune checkpoint inhibitors or targeted therapy) in the first-line or second-line setting. Circulating and urinary exosomal miRNA will be monitored during the first 16 weeks of treatment using blood and urine samples. Receives: Other: Blood and Urine Sampling for Exosomal miRNA Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Exosomal miRNA Expression and Objective Response
To determine whether changes in the expression of target plasma exosomal miRNA after initiation of systemic treatment are associated with objective response to treatment in patients with advanced renal cell carcinoma receiving immune checkpoint inhibitors or targeted therapy.
Measured: During the first 16 weeks of treatment
Secondary outcomes (1)
Change in Urinary Exosomal miRNA Expression and Objective Response
To determine whether changes in the expression of target urinary exosomal miRNA after initiation of systemic treatment are associated with objective response to treatment in patients with advanced renal cell carcinoma.
Measured: During the first 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start2 Nov 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406646
- Sponsor's protocol ID
- OI-EXO-RENAL1
- Other IDs
- ERID-KSOPKR-0083/2021
- Acronym
- EXO-RENAL1
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Monitoring of the Circulating and Urinary Exosomal miRNA for Prediction of Response to Treatment in Patients With Advanced Kidney Cancer
- ClinicalTrials.gov ID
- NCT07406646
- Acronym / sponsor ID
- EXO-RENAL1 / OI-EXO-RENAL1
- Conditions
- Renal Cell Carcinoma, Advanced Kidney Cancer
- Keywords
- Exosomal miRNA, Circulating Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective cohort study will investigate whether changes in circulating and urinary exosomal biomarkers (target exosomal miRNA) are associated with response to systemic treatment in patients with advanced renal cell carcinoma. Patients treated with immune checkpoint inhibitors or targeted therapies in the first-line or second-line setting will be included. Exosomal biomarker expression will be analyzed in blood and urine samples collected during the first 16 weeks of treatment. Treatment response will be assessed using standard radiological imaging. The study aims to determine whether changes in exosomal miRNA expression after treatment initiation can serve as predictive biomarkers of objective response in advanced kidney cancer.
Detailed description
This is a prospective observational cohort study conducted at the Institute of Oncology Ljubljana. The study will evaluate the predictive value of circulating and urinary exosomal biomarkers (target exosomal miRNA) for response to systemic therapy in patients with advanced renal cell carcinoma.
Patients receiving immune checkpoint inhibitors or targeted therapy in the first-line or second-line treatment setting will be enrolled. The primary objective is to determine whether changes in the expression of selected exosomal miRNA in plasma after initiation of systemic treatment are associated with objective response to therapy. In addition, urinary exosomal miRNA will be evaluated as a potential predictive biomarker.
Blood and urine samples will be collected during the first 16 weeks of treatment. Each participant will provide four peripheral blood samples (10 mL each) and two urine samples (50 mL each). Radiological imaging will be performed as part of routine clinical follow-up to assess treatment response. The association between changes in exosomal miRNA expression and treatment outcomes will be analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXO-RENAL1 Cohort | Other | Other: Blood and Urine Sampling for Exosomal miRNA AnalysisPatients with advanced renal cell carcinoma receiving standard-of-care systemic treatment (immune checkpoint inhibitors or targeted therapy) in the first-line or second-line setting. Circulating and urinary exosomal miRNA will be monitored during the first 16 weeks of treatment using blood and urine samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 years).
- Histologically confirmed advanced renal cell carcinoma.
- Patients receiving systemic treatment with immune checkpoint inhibitors or targeted therapy in the first-line or second-line setting.
- Ability to provide blood and urine samples according to the study protocol.
- Signed informed consent.
Key exclusion criteria (3 listed)
- Patients unable to provide required biological samples.
- Patients with missing clinical or imaging data required for treatment response assessment.
- Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and Urine Sampling for Exosomal miRNA AnalysisCollection of peripheral blood and urine samples for analysis of circulating and urinary exosomal miRNA during the first 16 weeks of systemic treatment in patients with advanced renal cell carcinoma. | Other | EXO-RENAL1 Cohort |
Primary outcome
Change in Plasma Exosomal miRNA Expression and Objective Response
Time frame: During the first 16 weeks of treatment
To determine whether changes in the expression of target plasma exosomal miRNA after initiation of systemic treatment are associated with objective response to treatment in patients with advanced renal cell carcinoma receiving immune checkpoint inhibitors or targeted therapy.
1 secondary outcome
Change in Urinary Exosomal miRNA Expression and Objective Response
Time frame: During the first 16 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and Urine Sampling for Exosomal miRNA Analysis in people with Renal Cell Carcinoma and Advanced Kidney Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Exosomal miRNA Expression and Objective Response (time frame: During the first 16 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.